2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Watson Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Iron Deficiency Anemia

Treatments: Drug: Oral Iron; Drug: Sodium Ferric Gluconate Complex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00223977

FR03001

Details and patient eligibility

About

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, at least 18 years of age.
• Received maintenance peritoneal dialysis therapy for at least 4 weeks.
• Was expected to remain on peritoneal dialysis therapy for duration of study.
• Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
• Signed patient informed consent.

Exclusion criteria

• Had a predetermined serum levels of Ferritin and TSAT
• Pregnant or lactating.
• Had a serious concomitant medical disorder incompatible with participation in the study.
• Had a known hypersensitivity to Ferrlecit or any of its components.
• Unable to cooperate or comply with the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

146 participants in 3 patient groups

Sodium ferric gluconate complex 125 mg

Experimental group

Description:

125 mg sodium ferric gluconate weekly x 8 weeks

Treatment:

Drug: Sodium Ferric Gluconate Complex

Drug: Sodium Ferric Gluconate Complex

Sodium ferric gluconate complex 250 mg

Experimental group

Description:

250 mg sodium ferric gluconate complex weekly x 4 weeks

Treatment:

Drug: Sodium Ferric Gluconate Complex

Drug: Sodium Ferric Gluconate Complex

Oral iron

Active Comparator group

Description:

325 mg ferrous sulfate three times daily x 8 weeks

Treatment:

Drug: Oral Iron